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Completed

NCT Number: NCT06016959

Specialist Dietetic Intervention in Malnourished Patients with Fibrotic ILD: a Randomised Controlled Pilot Trial

Malnutrition occurs when the body receives too few nutrients, resulting in health problems such as weight loss. The consequences of malnutrition are worrying as they include lung failure, infection, and pressure ulcers.

Interstitial Lung Disease (ILD) is a term used for a group of diseases which can cause scarring of the lungs. Having ILD can cause malnutrition due to the lungs working hard and burning off energy. Additionally, medications called anti-fibrotic agents are used to slow disease progression. However, side effects include poor appetite, diarrhoea, nausea, vomiting and weight loss which can result in malnutrition.

Malnutrition occurs in ILD in approximately half of patients. This is important because the main signs of malnutrition such as weight loss and a low Body Mass Index (BMI), which takes into consideration your weight against your height, are linked with worse outcomes in ILD. Malnutrition in ILD can also reduce eligibility for lung transplant and can impact tolerability of anti-fibrotic agents. Research into treatment of malnutrition in ILD is limited.

Dietitians play a key role in diagnosis and treatment of malnutrition. This is because dietary counselling by a dietitian has been shown to increase quality of life and intake of energy in other chronic diseases. There are currently no studies documenting the benefits of dietetic intervention in patients with ILD.

We propose to undertake the first feasibility study in this area. A feasibility study is a first step trial which investigates whether a study can & should be done. The main aims of this study are:

1. How easy it is to recruit ILD patients to see a dietitian 2. Whether patients will attend dietetic appointments 3. Whether food/nutrient intake is increased following dietetic intervention 4. How acceptable is dietetic intervention to ILD patients As well as these main aims, this study will also provide initial information about whether dietetic intervention stabilises weight, BMI & quality of life.

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Key information

Conditions

Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Brompton Hospital

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI ≤ 20kg/m2, or if aged >75, BMI ≤ 21 (Righini et al., 2013)
  • Over the past 12 months, unintentional weight loss ≥ 5% of body weight, regardless of baseline BMI or weight loss >2 kg if BMI is normal.

Exclusion criteria

  • Co-morbidities currently requiring a specialised diet (including enteral feeding)
  • End of life care (estimated less than 6 weeks left to live)
  • Expected introduction of anti-fibrotic or immunosuppressive treatment or introduction/increase corticosteroid dose during trial period
  • Pregnancy
  • Unable to give consent

Treatment and study plan

Dietetic intervention

Other

Dietetic intervention involves individualised and tailored dietary advice to patients struggling with their nutrition. This includes optimising energy and protein intake to improve malnutrition & also giving dietary advice to support with nutrition impact symptoms e.g. bloating.

Diet sheet (placebo)

Other

Patients randomised into the group receiving a diet sheet will be sent out Royal Brompton & Harefield Hospital's Poor Appetite diet booklet which involves general strategies to improve nutritional status (energy and protein)

Primary outcomes

  1. Recruitment rate

    Time frame: 8 months

    Number individuals recruited/Number individuals contacted

  2. Completion rate

    Time frame: 3 months

    Number individuals completing study/Number individuals randomised

  3. Compliance

    Time frame: Defined by increased energy & protein intake versus run-in (three-day diet-diaries).

    3 months

Secondary outcomes

  1. Nutritional status (Malnutrition)

    Time frame: 3 months

    PG-Subjective Global Assessment (SGA) which is a nutrition assessment tool using clinical parameters including weight loss, GI symptoms & functional capacity to diagnose malnutrition (Bauer et al., 2011).

  2. Nutritional status (gastrointestinal related symptoms)

    Time frame: 3 months

    Gastrointestinal symptoms will be measured via the Gastrointestinal Symptom Rating Scale (GSRS) to further understand severity and impact of gastrointestinal related symptoms. (Svedlund et al., 1988)

  3. Anthropometrics (weight)

    Time frame: 3 months

    Weight (kg) will be measured by VitaFit™ FCC/CE certified digital weighing scales provided during the first appointment or delivered at home, measured to an accuracy of 0.05kg. Dietitian led support for their use will be available.

  4. Anthropometrics (height)

    Time frame: 3 months

    Height (m) will be derived from the most recent lung function reports.

  5. Anthropometrics (Body Mass Index)

    Time frame: 3 months

    With the anthropometrics measured weight (kg) and height (m), this will be used to calculate Body Mass Index (BMI (kg/m2)).

  6. Handgrip strength

    Time frame: 3 months

    Optimum nutrition can support maintenance of muscle to support activities of daily living. A CAMRY™ digital hand dynamometer will be delivered at home. HGS (kg) measures maximum voluntary muscle strength by squeezing the dynamometer providing a grip measurement accurate to 0.1kg.

  7. Quality of Life (QoL)

    Time frame: 3 months

    Improved nutrition status may positively impact QoL. The King's Brief Interstitial Lung Disease Questionnaire (K-BILD), a 15-widely validated ILD-specific QoL questionnaire, will be used.

  8. Energy and Protein intake

    Time frame: 3 months

    Participants will undertake a three-day diet diary at baseline and at 3 months to measure intake of macro and micronutrients will be calculated by using the software NutriticsTM, including daily total energy and protein intake as well as other nutrients, if necessary.

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Registry information

Acronym: DT-ILD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2023
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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